Multi-purpose balloon catheter for intra cavity radiation delivery

ABSTRACT

A multi-purpose balloon intra-cavity catheter includes a catheter having a proximal end portion, a central portion and a non-branching distal end portion, a plurality of lumens associated with the catheter extending from the proximal end portion, and a plurality of inflatable balloons positioned in the central portion and/or the non-branching distal end portion. Each of the plurality of inflatable balloons is communicatively associated with a corresponding one of the plurality of lumens, the plurality of inflatable balloons being selectively inflated or deflated to position and stabilize the catheter in a cavity for delivery of a medical treatment. The catheter can include an extraction opening associated with a lumen to remove fluids and materials from the cavity, and a connector associated with a corresponding lumen adapted to selectively receive one or more of a fluid medium or a radioactive isotope provided to a corresponding lumen for delivery of the medical treatment.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority under 35 U.S.C. § 120 to and is adivisional application of U.S. patent application Ser. No. 15/292,923,filed on Oct. 13, 2016, now issued as U.S. Pat. No. 10,744,307, whichclaims priority under 35 U.S.C. § 120 to and is a continuation-in-part(CIP) of U.S. patent application Ser. No. 15/189,396, filed on Jun. 22,2016, now issued as U.S. Pat. No. 10,406,381, which claims priorityunder 35 U.S.C. § 120 to and is a divisional application of U.S. patentapplication Ser. No. 12/889,032, filed on Sep. 23, 2010, now issued asU.S. Pat. No. 9,402,980, and U.S. patent application Ser. No. 15/292,923also claims priority under 35 U.S.C. § 119 to U.S. Provisional PatentApplication No. 62/242,972, filed on Oct. 16, 2015, all of which arehereby incorporated by reference in their entirety.

FIELD OF THE INVENTION

The invention generally relates to medical devices, and moreparticularly to a multi-purpose balloon catheter having a plurality ofballoons for selectively stabilizing and positioning the catheter, fordelivering a radiation dose, for measuring and imaging internal organs,cavities, and removing bodily fluids or material while providing an easyconnection module for treatment.

BACKGROUND

A catheter is a tube that can be inserted into a body cavity, duct, orvessel. Catheters thereby allow drainage, injection of fluids, or accessby surgical instruments. The process of inserting a catheter iscatheterization. In most uses, a catheter is a thin, flexible tube(“soft” catheter), though in some uses, it is a larger, solid (“hard”)catheter. A catheter left inside the body, either temporarily orpermanently, may be referred to as an indwelling catheter. A permanentlyinserted catheter may be referred to as a Permcath®, for example.

The ancient Syrians created catheters from reeds. “Katheter—καθετηρ”originally referred to an instrument that was inserted such as a plug.The word “katheter” in turn came from “kathiemai—ηαθιεμαι” meaning “tosit”. The ancient Greeks inserted a hollow metal tube through theurethra into the bladder to empty it and the tube came to be known as a“katheter”.

Heretofore various balloon type catheters and perfusion catheters havebeen proposed for performing one or two procedures. However, heretofore,prior to the present invention, a multi-purpose balloon catheter capableof performing two or more procedures has not been available.

The incidence of esophageal and stomach cancers continue to increaseglobally. Often patients die without proper diagnosis and/or treatment.For localized cancers, tumors can be first shrunk with the help of highdose rate brachytherapy employing appropriate applicators. This can befollowed by surgical, chemotherapeutic and/or biological agents ormediated targeted therapeutic procedures. Positioning and targeting ofradiation to the site of disease with minimal or no damage to normalnearby organs remains a challenge. Thus, the need exists to have acatheter that can not only provide multiple functions but also can beselectively positioned and targeted for delivering the radiation orother suitable treatment modalities and other applications such asrectal, bladder, colon, uteral, cervical and breast cancers. Thecatheters of the present invention can address that need as well as canpromote minimizing risk of causing damage to surrounding tissue or canpromote reducing pain during a treatment procedure.

Thus, a multi-purpose balloon catheter for intra cavity radiationdelivery addressing the aforementioned problems is desired.

SUMMARY OF INVENTION

A multi-purpose balloon catheter includes a single intra-cavity catheterhaving a proximal end portion, a central portion and a non-branchingdistal end portion, a plurality of lumens positioned in association withthe catheter extending from the proximal end portion, and a plurality ofinflatable balloons arranged in a plurality of independent and distinctballoon groups. Each of the plurality of inflatable balloons arepositioned in association with one or more of the central portion and/orthe non-branching distal end portion of the single intra-cavitycatheter. Each of the plurality of inflatable balloons iscommunicatively connected to a corresponding one of the plurality oflumens, the plurality of inflatable balloons being selectively inflatedor deflated to position and/or stabilize the catheter in a cavity fordelivery of a medical treatment or selectively filled with a treatmentmedium, such as a radioactive material, or a contrast medium, fordelivery of the medical treatment.

The multi-purpose balloon catheter can include a secondary treatmentballoon positioned at the non-branching distal end portion of the singleintra-cavity catheter and communicatively connected to one or more ofthe plurality of lumens, and at least one of the plurality of lumens isadapted to provide a medium to selectively inflate or deflate thesecondary treatment balloon to selectively position and/or stabilize thesecondary treatment balloon for delivery of the medical treatment andanother of the plurality of lumens adapted to deliver a radioactive doseor a therapeutic agent or therapeutic medium for the medical treatment.In addition, a radioactive wire can be inserted into one of the lumensto deliver radiation to an internal organ or cavity of a patient. Themulti-purpose balloon catheter can further include a marker placed inassociation with the non-branching distal end portion of the singleintra-cavity catheter to indicate a position of the catheter.

These and other features of the present invention will become readilyapparent upon further review of the following specification anddrawings.

DESCRIPTION OF THE DRAWINGS

FIG. 1A is a longitudinal plan view of an embodiment of a multi-purposeballoon catheter according to the present invention.

FIG. 1B is a cross-sectional view taken along lines 1B-1B of FIG. 1A.

FIG. 1C is a plan view of an embodiment of a multi-purpose ballooncatheter according to the present invention having an embodiment of anapplicator extender in association with the distal position of thecatheter.

FIG. 1D is a cross-sectional view taken along lines 1D-1D of theembodiment of the catheter of FIG. 1C.

FIG. 1E is a plan view of an embodiment of a multi-purpose ballooncatheter according to the present invention having a treatment balloonconfiguration and an embodiment of an applicator extender in conjunctionwith an embodiment of a treatment balloon.

FIG. 1F is an embodiment of an applicator extender in conjunction withan embodiment of a treatment balloon that can be fitted in associationwith the distal end portion of the embodiment of the catheter of FIG.1E, or that can be fitted in association with the distal end portion ofthe embodiment of the catheter of FIG. 1A.

FIG. 1G is another embodiment of an applicator extender in conjunctionwith an embodiment of a treatment balloon that can be fitted inassociation with the distal end portion of the embodiment of thecatheter of FIG. 1E, or that can be fitted in association with thedistal end portion of the embodiment of the catheter of FIG. 1A.

FIG. 1H is a further embodiment of an applicator extender in conjunctionwith an embodiment of a treatment balloon that can be fitted inassociation with the distal end portion of the embodiment of thecatheter of FIG. 1E, or that can be fitted in association with thedistal end portion of the embodiment of the catheter of FIG. 1A.

FIG. 1I is a cross-sectional view taken along lines 1I-1I of theembodiment of the catheter of FIG. 1E.

FIG. 2A is a longitudinal plan view of an embodiment of a multi-purposeballoon catheter according to the present invention.

FIG. 2B is a cross-sectional view taken along lines 2B-2B of FIG. 2A.

FIG. 2C is a plan view of another embodiment of a multi-purpose ballooncatheter fitted with a treatment balloon in association with the distalend portion of the catheter, the treatment balloon having a spiral lumenor a longitudinal lumen adapted to receive a radioactive wire or aradioactive material.

FIG. 2D is an embodiment of a treatment balloon having a spiral lumen ora longitudinal lumen adapted to receive a radioactive wire or aradioactive material as can be with the embodiment of the catheter ofFIG. 2C.

FIG. 2E another embodiment of a treatment balloon having a spiral lumenor a longitudinal lumen adapted to receive a radioactive wire or aradioactive material as can be with the embodiment of the catheter ofFIG. 2C.

FIG. 2F is a cross-sectional view taken along lines 2F-2F of FIG. 2C.

Unless otherwise indicated, similar reference characters denotecorresponding features consistently throughout the attached drawings.

DETAILED DESCRIPTION

The present disclosure relates to a multi-purpose balloon catheter fordelivering a medical treatment, such as radiation, and for targetingsingle to multiple disease sites with a novel multi-balloonconfiguration. Additionally, the multi-purpose balloon catheter enablesfixing or positioning radioactive wires or radioactive material in acavity, such as in the esophagus, in other organs or in a surgicallycreated cavity, to deliver the medical treatment, such as radiation or atherapeutic agent to a targeted portion of an organ or surgicallycreated cavity using a conformable device including balloons, lumens anda single intra-cavity catheter. Moreover, the multi-purpose ballooncatheter allows for diagnosing the anatomy of an abnormal organ shape byevaluating the balloon shape (with contrast agent) by comparing toshapes of normal healthy patient organs. The multi-purpose ballooncatheter allows for the medical treatment of multiple sites withdiseases using the same device (esophageal and stomach cancers).Finally, the multi-purpose balloon catheter allows for the medicaltreatment of one organ while determining the dose delivered to a nearbynormal organ with a small dosimeter (MOSFET system).

Referring now to the drawings in greater detail, there is illustrated inFIG. 1A, an embodiment of a multi-purpose balloon catheter 100 accordingto the teachings of the invention. The multi-purpose balloon catheter100 includes a proximal end portion 121, a central portion 122 having,for example, a generally tubular shaped body 103, and a non-branchingdistal end portion 123, with the non-branching distal end portion 123including a suitable marker such as a X-ray marker 125 to indicate aposition of the non-branching distal end portion 123 of themulti-purpose balloon catheter 100. The X-ray marker 125 typically canbe gold, lead, tungsten or other heavy metal suitable for X-rayvisualization, or can be other suitable material, depending on the useor application, and should not be construed in a limiting sense.

The multi-purpose balloon catheter 100 can be made of various suitablematerials, such as a polymeric material, such as a polyurethane or apolyacrylic material, among other examples, depending on the use orapplication, for example. Typically, a length 113 of the multi-purposeballoon catheter 100 of FIG. 1A is about 78 cm to the tip from the basearea of the multi-purpose balloon catheter 100, but the catheter 100 canbe of various suitable lengths and dimensions, depending on the use orapplication, for example. A diameter 114 of the catheter 100 of FIG. 1Ais typically 0.45 cm, but can be of various suitable diameters,depending on the use or application, for example.

The proximal end portion 121 of the catheter 100 includes the pluralityof neck portions 106 a, 106 b, and 106 c, made of similar suitablematerial as the catheter 100. The neck portions 106 a, 106 b, and 106 ceach include a corresponding lumen 101 a, 102 a and 105 a therein thatextends within the catheter 100 for balloon inflation or for thedelivery of the medical treatment, for example. The central lumen 102 abeing coaxially positioned within a larger main lumen extendinglongitudinally through the catheter 100 to the non-branching distal endportion 123. The neck portions 106 a, 106 b, and 106 c and correspondinglumens 101 a, 102 a and 105 a are desirably associated with acorresponding suitable connector or connecting mechanism 101, 102 and105, such as suitable luer locks 101, 102, and 105, that can be a maleor a female connection, for example.

For example, the luer-locks 101 and 105 can be fitted with syringes forselectively inflating balloons 111 a, 111 b, and 111 c and balloons 109a and 109 b to a predetermined size, for a particular use orapplication, for example. The balloons 111 a, 111 b, and 111 c and theballoons 109 a and 109 b being desirably located in the central portion122 to facilitate positioning and stabilizing the catheter 100 fordelivery of the medical treatment. In the catheter 100, the lumen 101 aassociated with the luer lock 101 can receive and remove a fluid medium,such as saline solution or a gaseous medium, such as by a syringe orother suitable delivery mechanism, such as a pump, to selectivelyinflate or deflate the balloons 111 a, 111 b, and 111 c.

Similarly, the lumen 105 a associated with the luer lock 105 can receiveand remove a fluid medium, such as saline solution or a gaseous medium,such as by a syringe or other suitable delivery mechanism, such as apump, to selectively inflate or deflate the balloons 109 a and 109 b,for example. The locking mechanism or connector, such as provided by theluer locks 101, 102 and 105, when affixed to the catheter 100 canprovide for selectively not allowing or selectively allowing a fluidmedium, such as including fluids, fluid or gaseous mediums, such as air,or allowing a contrast medium, for example, to pass through acorresponding connecting point provided by the connector or connectingmechanism 101, 102 and 105, such as luer locks, of the catheter 100.

As depicted in FIG. 1A, the central lumen 102 a associated with theconnector 102, such as a luer lock, can be used to insert a radioactivewire 107 as a radiation source or a radioactive material into thetreatment catheter 100, such radiation source or radioactive materialcan also include a radioactive seed for the delivery of the medicaltreatment at a specific site or at a predetermined location of the organor cavity. Also, the central lumen 102 a associated with the lockingmechanism or connector 102, such as a luer lock, can be used withsuction or a syringe to remove bodily fluids or material from a cavityin a body, such as an area adjacent to the cavity, using the treatmentcatheter 100, such as by communicating with an extraction opening 127 atthe non-branching distal end portion 123 of the catheter 100, such asillustrated in FIG. 1A, for example. The central lumen 102 a can bepositioned in a larger main lumen 103 a extending through the catheter100, as illustrated in FIG. 1A. The locking mechanism or connector 102for the lumen 102 a can allow for a relatively easier controlleddelivery and guidance for the medical treatment or extraction within atreatment area, for example.

Selectively inflating the balloons 109 a, 109 b, 111 a, 111 b and 111 ccan allow for selectively positioning and/or stabilizing the catheter100 or for administration of the medical treatment or for removal ofbodily fluids or material in a cavity, such as in a bodily organ or in acavity region, such as the esophagus, rectum, stomach or a surgicallycreated cavity, such as in the breast or other organ or bodily tissue,such as through the lumen 102 a, for example. The lumens 101 a and 105 aand the inflated balloons 109 a, 109 b, 111 a, 111 b and 111 c cancontain a contrast liquid or other contrast medium, such as for contrastpurposes in imaging applications, that can also be used for inflation ofthe balloons 109 a, 109 b, 111 a, 111 b and 111 c, for positioning,stabilization and treatment, for example. As illustrated in FIG. 1A, theballoons 109 a, 109 b, 111 a, 111 b and 111 c can be arranged in aplurality of independent and distinct balloon groups in association withthe central portion 122 of the catheter 100. For example, as illustratedin FIG. 1A, the balloons 109 a and 109 b can form a first balloon group,and the balloons 111 a, 111 b and 111 c can form a second balloon group.Each independent and distinct balloon group can be selectively inflatedor deflated or can also receive and can have removed a contrast liquidor other contrast medium independently of the balloons of anotherballoon group, such as through corresponding ones of the plurality ofconnectors, such as connectors 101 and 105, and through the associatedcorresponding ones of the plurality of the lumens, such as lumens 101 aand 105 a, for example.

As discussed herein, the catheter 100 includes a plurality of balloons,such as the balloons 109 a, 109 b, 111 a, 111 b and 111 c that may bearranged in a plurality of independent and distinct balloons groups,such as the first balloon group including balloons 109 a and 109 b andthe second balloon group including balloons 111 a, 111 b, and 111 c. Thelumens of the catheter 100, such as the lumens 101 a and 105 a, can becommunicatively connected to a single or to any of various pluralitiesof balloons. For example, the lumen 101 a can be connected with balloons111 a, 111 b, 111 c of the second balloon group and the lumen 105 a canbe connected to balloons 109 a and 109 b of the first balloon group, asillustrated in FIG. 1A, for example. Also, the catheter 100 can have anyof various other suitable connection arrangements with more or lesslumens or balloons, depending on the use or application, for example.Further, the balloons, such as the balloons 109 a, 109 b, 111 a, 111 band 111 c, can have any of various suitable sizes or shapes, such ascylindrical, spherical, oval, oblong, toroidal, or other suitableshapes, depending on the use or application, for example.

The lumens, such as the lumens 101 a, 102 a and 105 a, can have any ofvarious suitable sizes, shapes or configurations, such as cylindrical,rectangular, oval, or other suitable shapes or configurations, dependingon the use or application, for example. Also, a typical dimension of adiameter of the lumens, such as indicated at 117 for diameter of thelumen 105 a, as indicated at 129 for a diameter of the lumen 101 a, andas indicated at 131 for a diameter of the lumen 102 a, for inflating theballoons 109 a, 109 b, 111 a, 111 b and 111 c and/or for delivery of themedical treatment, can be typically in a range of from about 0.8 mm toabout 1.5 mm, for example, but can be of various suitable dimensions,depending on the use or application, and should not be construed in alimiting sense.

Further, the spacing between each of the centers of adjacent ones of theballoons 109 a, 109 b, 111 a, 111 b and 111 c, desirably correspondingto the spacing between adjacent exit points of the lumens 101 a and 105a of respective adjacent balloons, can be a same or a different spacing,depending on the use or application, such as desirably being spacedapart by about 2.5 cm from each other as indicated at 115, for example.The first balloon group including the balloons 109 a and 109 b isindependently arranged from the second balloon group including theballoons 111 a, 111 b and 111 c on the catheter 100 along the length 113of the catheter 100, such as illustrated in FIG. 1A. Also, the lumens,such as the lumens 101 a, 102 a and 105 a, can be positioned within aninterior of the catheter 100, such interior of the catheter 100 beingindicated by the numeral 119, or can be positioned or integrally formedon or in an exterior surface or layer of the catheter 100, for example,depending on the use or application, for example.

The balloons, such as the balloons 109 a, 109 b, 111 a, 111 b and 111 c,can be made of nylon, polyurethane, Polyether block amide Pebax®poly(ethylene terephthalate), commonly abbreviated PET or otherthermoplastic elastomers or other suitable materials, depending on theuse or application, for example. Additionally, one or more of theballoons 109 a, 109 b, 111 a, 111 b and 111 c and all or part of thecatheter 100, such as the body 103 of the central portion 122 of thecatheter 100, can be coated or impregnated with various suitablecoatings for ease of assembly such as a silicone type coating, or theballoons can be impregnated or coated with various suitable therapeuticor medicinal agents for treatment at a site within the body, such as byelution of the agent from the balloon or the catheter, for example.

In an embodiment, the catheter 100, as well as the balloons associatedwith the catheter 100, such as the balloons 109 a, 109 b, 111 a, 111 b,and 111 c, can be uncoated or can be coated with a lubricant forlubrication for ease of positioning the catheter 100 at a treatmentsite, or can be coated or formed with antimicrobial or medicinal agentsfor delivery of the medical treatment at the treatment site, forexample. In this regard, in various embodiments of catheters, such asthe catheter 100, various therapeutic drugs can be coated onto thesurface of the balloons or catheter for releasing the drug internally toa specific location of the cavity being treated.

The catheter 100 of FIG. 1A having a plurality of connectors or lockingmechanisms, such as the luer-locks 101, 102 and 105 as examples ofconnectors or locking mechanisms, and a plurality of balloons, such asthe balloons 109 a, 109 b, 111 a, 111 b, and 111 c, can be inserted intovarious body cavities, such as the esophagus, but is not limited theretoand can also be inserted for the medical treatment into other cavities,such as the rectum, vagina, etc. or surgically created cavities, whereinthe radioactive wire, radioactive seed or other radioactive ortherapeutic material or other therapeutic agent, can provide therequisite radiation dose or therapeutic agent to treat cancerous growthor other medical conditions. Typically, the dimension of the radioactivewire, such as the radioactive wire 107, that can be inserted into thelumen 102 a, is desirably in a range of about 0.5 mm to about 0.8 mm,for example, but can be of various suitable dimensions andconfigurations, depending on the use or application.

Desirably, the radioactive wire, such as the radioactive wire 107, ismade of a suitable radioactive material, such as Iridium-192, Cobalt 60and Yttrium 168, for example. The high dose rate (HDR) treatmentdelivered through the catheter, such as the catheter 100, can beconducted with Ir-192, Au-198, I-125 and Cs-131, for example. Typicallythe dose of radiation delivered by the radioactive wire, such as theradioactive wire 107, is about 1 Curie to about 10 Curies per seed, butcan be any suitable dose, depending on the use or application. Also, HDRafterloaders can be used in conjunction with embodiments of thecatheters, such as the catheter 100, for the delivery of a radiationdose for the medical treatment, such as Varisource, Gamma Med and BEBIGafterloaders or other suitable afterloaders, for example.

For a low dose rate (LDR) application delivered through embodiments ofcatheters, such as the catheter 100, Sr-90 can be used in conjunctionwith the radiation wire, such as the radioactive wire 107, as well asCs-131 and Yb-168 can also be used as the radiation source, for example.Typically the dose of radiation using the LDR configuration is usuallyone thousand times less than the HDR applications, such LDR dose beingin a range of about 1 milli Curie to about 10 milli Curies, for example.

An advantage, among others, of embodiments of catheters, such as thecatheter 100, is that it can allow for delivering the radiation dose toa specific or a predetermined site or location of or in the cavity, suchas in an organ, a body cavity or a surgically created cavity, such as bythe radioactive wire 107, through the lumen 102 a, and can also allow,at the same time or at different times, for the removal of fluid orbodily material, from the area of the treatment site, such as throughthe lumen 102 a or the main lumen 103 a, for example, while alsoproviding enhanced stabilization and positioning of the catheter, suchas the catheter 100, for the medical treatment, by selective inflationor deflation of the corresponding balloons, such as the balloons 109 a,109 b, 111 a, 111 b, and 111 c, for example, that can allow selectivelycontrolling the size of each balloon independently or in conjunctionwith one or more other balloons, to selectively adjust the location andpositioning of the catheter at the treatment site.

FIG. 1B shows the cross-sectional view taken along the 1B-1B plane ofthe catheter 100 of FIG. 1A. The catheter 100 is illustrated in sectionin FIG. 1B along with relative positions of the lumens 101 a, 102 a and105 a, for example. Also, FIG. 1B illustrates a relative position of theradioactive wire 107 within the lumen 102 a. The central lumen 102 aallows for selectively inserting and positioning the radioactive wire,such as the radioactive wire 107, a radioactive seed or other suitabletreatment medium, for delivery of the medical treatment, for example.

Referring to FIG. 1C, another embodiment of a multi-purpose balloonsingle intra-cavity catheter 300 is illustrated. The catheter 300 issimilar to the catheter 100 of FIG. 1A, as described, including theballoons 109 a, 109 b, 111 a, 111 b, 111 c, and the corresponding lumens101 a, 102 a and 105 a with the connectors or locking mechanisms 101,102 and 105, as described, and can be of suitable shapes, dimensions andmaterials, as described in relation to the catheter 100. However, thecatheter 300 also includes an embodiment of an applicator extender 505communicatively associated with the non-branching distal end portion 123of the catheter 300, the applicator extender 505 being configured to bein communication with the central portion 122 of the catheter 300 fordelivering the medical treatment. The applicator extender 505 includes alower portion or a lower chamber 507 and an upper portion or an upperchamber 509 for delivering a radiation dose, such as to the esophagus,such as through the radioactive wire 107, for example.

A secondary treatment radiation balloon wire can be inserted into theapplicator extender 505 through the middle section having a membranethat can be made of silicone, to deliver a treatment fluid or treatmentmedium, for example. The applicator extender 505 can be associated withor include a suitable connector or fastening mechanism 511, such as asuitable luer lock, to allow fitting the applicator extender 505 withthe catheter 300 in association with the non-branching distal endportion 123 of the catheter 300 end, such as in FIG. 1C, for example.The applicator extender 505 in conjunction with an embodiment of atreatment balloon is illustrated in greater detail and further describedherein in relation to FIGS. 1F, 1G and 1H.

FIG. 1D illustrates is a cross-sectional planar view taken along the1D-1D plane of the catheter 300 of FIG. 1C. The catheter 300 isillustrated in section in FIG. 1D along with relative positions of thelumens 101 a, 102 a and 105 a, for example. Also, FIG. 1D illustrates arelative position of the radioactive wire 107 within the lumen 102 a.The central lumen 102 a allows for selectively inserting and positioningthe radioactive wire, such as the radioactive wire 107, or othersuitable treatment medium, for delivery of the medical treatment, forexample.

Referring to FIG. 1E, another embodiment of a multi-purpose balloonsingle intra-cavity catheter 400 is illustrated. The catheter 400 issimilar to the catheter 100 of FIG. 1A and the catheter 300 of FIG. 1C,as described, including the balloons 109 a, 109 b, 111 a, 111 b, 111 c,and the corresponding lumens 101 a, 102 a and 105 a with the connectorsor locking mechanisms 101, 102 and 105, as described, and can be ofsuitable shapes, dimensions and materials, as described in relation tothe catheters 100 and 300. However, the catheter 400 also includes anembodiment of an applicator extender balloon assembly 500 at thenon-branching distal end portion 123 of the catheter 400 that includesthe applicator extender 505, such as also illustrated in FIG. 1C, and anembodiment of a secondary treatment balloon 550.

The applicator extender 505 provides a connection with the lumen 102 afor delivery of a radiation dose, or for delivery of a therapeuticagent, to the secondary treatment balloon 550 for the medical treatment,such as to a cavity formed by or in the stomach or a surgically createdcavity, such as through the radioactive wire 107, for example. Asecondary treatment radiation balloon wire, such as the radioactive wire107, can be inserted into the lumen 102 a and through the applicatorextender 505 through the middle section having a membrane that can bemade of silicone, and can also deliver a treatment fluid or treatmentmedium, for example, to the secondary treatment balloon 550.

The secondary treatment balloon 550 includes an outer secondarytreatment balloon 552 and an inner secondary treatment balloon 554. Theouter secondary treatment balloon 552 and the inner secondary treatmentballoon 554 can be selectively inflated or deflated to be positioned ina body cavity or a surgically created cavity to be treated and the innersecondary treatment balloon 554 is associated with at least onesecondary treatment lumen communicatively connected with the lumen 102 afor delivery and removal of a radiation dose, a therapeutic agent orother medical treatment, to be further described in relation to FIGS.1F, 1G and 1H.

Additionally, the catheter 400 includes neck portions 106 d and 106 eand corresponding lumens 104 a and 108 a that are desirably associatedwith a corresponding suitable connector or connecting mechanism 104 and108, such as suitable luer locks 104 and 108, which can be a male or afemale connection, for example. The lumens 104 a and 108 a can beextended through the applicator extender 505, such as by a suitableconnector lumen in the applicator extender 505, to be placed incommunication with the secondary treatment balloon 550. The lumen 104 ais communicatively positioned in association with the inner secondarytreatment balloon 554 and the lumen 108 a is communicatively positionedin association with the outer secondary treatment balloon 552 torespectively selectively inflate or deflate the inner secondarytreatment balloon 554 and the outer secondary treatment balloon 552 toposition and stabilize the secondary treatment balloon 550 in a bodycavity to be treated.

Similarly, the lumens 104 a and 108 a associated with the luer locks 104and 108, respectively, can receive and remove a fluid medium, such assaline solution or a gaseous medium, such as by a syringe or othersuitable delivery mechanism or machine, such as a pump, to selectivelyinflate or deflate the inner secondary treatment balloon 554 and theouter secondary treatment balloon 552, to provide a correspondingballoon, shape, size and configuration in the body cavity for thetreatment, for example.

Additionally, the applicator extender 505 can be associated with orinclude a suitable connector or fastening mechanism 511, such as asuitable luer lock, to allow fitting with the catheter 400 inassociation with the non-branching distal end portion 123 of thecatheter 400, such as in FIG. 1E, for example. The applicator extender505 and the secondary treatment balloon 550 can be associated with afurther connector or locking mechanism 143, such as a luer lock, toallow selective fitting of the applicator extender 505 with thesecondary treatment balloon 550 to allow for secondary treatmentballoons 550 of different sizes, shapes and configurations to becommunicatively connected with the applicator extender 505 for deliveryof the medical treatment, for example.

Also, the applicator extender 505 and the secondary treatment balloon550, as well as the applicator extender balloon assembly 500, can beintegrally formed together with each other and with the catheter 400, orcan also suitably be joined together by other suitable processes andmethods, such as with a suitable adhesive, glue or tape in addition tothe locking mechanism or connector, such as the luer locks 511 and 143,for example. The applicator extender balloon assembly 500 including theapplicator extender 505 and various exemplary embodiments of thesecondary treatment balloon 550 are illustrated in greater detail andfurther described herein in relation to FIGS. 1F, 1G and 1H.

Referring now to FIG. 1F, there is illustrated the catheter 400 with anembodiment of the applicator extender balloon assembly 500 that includesan embodiment of the applicator extender 505 and an embodiment of thesecondary treatment balloon 550 associated with the catheter 400 andwith the various lumens of FIG. 1E, in greater detail. In the embodimentof the applicator extender balloon assembly 500 of FIG. 1F, theapplicator extender 505 and the secondary treatment balloon 550 areintegrally formed or are joined together with each other at 510, such asby being suitably joined together by suitable processes and methods,such as with a suitable adhesive, glue or tape, for example. In theembodiment of applicator extender balloon assembly 500, the applicatorextender 505 can be suitably joined to the catheter 400 by a suitablelocking mechanism or connector, such as the luer lock 511, or can beintegrally formed or are joined together with the catheter 400, such asby being suitably joined together by suitable processes and methods,such as with a suitable adhesive, glue or tape, for example.

The applicator extender 505 in FIG. 1F, also includes a lower orproximal chamber 507 and a distal or upper chamber 509 that can receivea radioactive or other therapeutic medium or a contrast medium, such asthrough the central lumen 102 a, for example. The applicator extender505 can include a base 503 having a suitable membrane or being made froma suitable material to allow passage of one or more lumens, and an outerwall 501 that can form respective portions of the lower chamber 507 andthe upper chamber 509 and that can be communicatively connected to theconnector or locking mechanism 511 or that can be otherwisecommunicatively connected to the catheter 400, as described. The lowerchamber 507 and the upper chamber 509 each can selectively include asuitable fluid medium or a treatment agent, such as a radioactive fluidor a contrast agent, that can be used for mapping a position or for themedical treatments and can be selectively introduced though the centrallumen 102 a, for example.

The applicator extender 505 also includes an aperture 504 a that can beselectively opened or closed by a gate member 504 that can be eitheradapted to be perforated or that can be adapted to be selectively openedor closed by passage or removal of the central lumen 102 a or of anextension thereof in the applicator extender 505, as described, and/orby the lumens 104 a and 108 a or an extension thereof in the applicatorextender 505, as described. The gate member 504 can be formed in or as apart of a separation wall 504 b, formed between the lower chamber 507and the upper chamber 509, and can be made from silicone, a rubber typematerial, or other suitable material, or can be a membrane of a suitablematerial, for example.

As described in relation to FIG. 1E, the lumens 104 a and 108 a can beextended through the applicator extender 505, such as by a suitableconnector lumen in the applicator extender 505, to be placed incommunication with the secondary treatment balloon 550. The lumen 104 ais in communication with the inner secondary treatment balloon 554 andthe lumen 108 a is in communication with the outer secondary treatmentballoon 552 to respectively selectively inflate or deflate the innersecondary treatment balloon 554 and the outer secondary treatmentballoon 552 to position and/or stabilize the secondary treatment balloon550, the outer secondary treatment balloon 552 and/or the innersecondary treatment balloon 554, in a body cavity to be treated.

Similarly, the lumens 104 a and 108 a can receive and remove a fluidmedium, as previously described, such as saline solution or a gaseousmedium, such as by a syringe or other suitable delivery mechanism, suchas a pump, to selectively inflate or deflate the inner secondarytreatment balloon 554 and the outer secondary treatment balloon 552, toprovide a corresponding balloon, shape, size and configuration in thebody cavity for the treatment, for example.

The inner secondary treatment balloon 554 has at least one or both of afirst secondary treatment lumen 556 and a second secondary treatmentlumen 560. The first secondary treatment lumen 556 can be positioned inassociation with the periphery of the inner secondary treatment balloon554 and can be integrally formed with or affixed to or otherwisepositioned in conjunction with the inner secondary treatment balloon554, such as by a suitable glue or adhesive, for example. The firstsecondary treatment lumen 556 can be positioned in association with theperiphery of the inner secondary treatment balloon 554, such as eitherin association with an interior surface or in association with anexterior surface of the inner secondary treatment balloon 554, desirablyin a generally spiral type configuration, such as illustrated in FIG.1F, for example. The first secondary treatment lumen 556 iscommunicatively connected to the central lumen 102 a or an extensionthereof in the applicator extender balloon assembly 500 by a connectoror connector portion 558 to deliver a radioactive dose or other medicaltreatment through the central lumen 102 a to a treatment site in acavity, such as by insertion of the radioactive wire 107 or providing atherapeutic agent through the central lumen 102 a, the connector 558 andthe first secondary treatment lumen 556, for example.

In the inner secondary treatment balloon 554, the second secondarytreatment lumen 560 can be integrally formed with or affixed to orotherwise positioned in conjunction with the inner secondary treatmentballoon 554, such as by a suitable glue or adhesive, for example. Thesecond secondary treatment lumen 560 is communicatively connected to thecentral lumen 102 a by a connector or connector portion 559 to deliver aradioactive dose or other medical treatment through the central lumen102 a to a treatment site in a cavity, such as by insertion of theradioactive wire 107 or providing a therapeutic agent through thecentral lumen 102 a, the connector 559 and the second secondarytreatment lumen 560, for example. The second secondary treatment lumen560 is desirably formed in an interior portion of the inner secondarytreatment balloon 554 desirably extending in a generally longitudinaldirection in a generally central portion of the inner secondarytreatment balloon 554, for example.

Referring now to FIG. 1G, there is illustrated the catheter 400 with anembodiment of the applicator extender balloon assembly 500 that includesan embodiment of the applicator extender 505 and an embodiment of thesecondary treatment balloon 550 associated with the catheter 400 andwith the various lumens of FIG. 1E, in greater detail. The applicatorextender balloon assembly 500 in association with the catheter 400 inFIG. 1G has similar components and structure to that described withrespect to the applicator extender balloon assembly 500 illustrated inFIG. 1F. However, in the applicator extender balloon assembly 500 ofFIG. 1G, there is included a connector or locking mechanism 143, such asa suitable luer lock, that can include suitable male or femaleconnectors 143 a and 143 b to connect the applicator extender 505 andthe secondary treatment balloon 550 for a treatment. Also, in theapplicator extender balloon assembly 500 of FIG. 1G the inner secondarytreatment balloon 554 can only include, for example, the secondsecondary treatment lumen 560 and the connector 559, with the firstsecondary treatment lumen 556 being optionally indicated by the dashedlines and the connector 558 (illustrated in FIG. 1F) not being shown inFIG. 1G.

Referring now to FIG. 1H, there is illustrated the catheter 400 with anembodiment of the applicator extender balloon assembly 500 that includesan embodiment of the applicator extender 505 and an embodiment of thesecondary treatment balloon 550 associated with the catheter 400 andwith the various lumens of FIG. 1E, in greater detail. The applicatorextender balloon assembly 500 in association with the catheter 400 inFIG. 1H has similar components and structure to that described withrespect to the applicator extender balloon assembly 500 illustrated inFIG. 1F. However, in the applicator extender balloon assembly 500 ofFIG. 1H, there is included a connector or locking mechanism 143, such asa suitable luer lock, that can include suitable male or femaleconnectors 143 a and 143 b to connect the applicator extender 505 andthe secondary treatment balloon 550 for a treatment. Also, in theapplicator extender balloon assembly 500 of FIG. 1H the inner secondarytreatment balloon 554 can only include, for example, the first secondarytreatment lumen 556 and the connector 558, with the second secondarytreatment lumen 560 and the connector 559 being optionally indicated bythe dashed lines.

Referring to FIG. 1I, there is illustrated is a cross-sectional planarview taken along the 1I-1I plane of the catheter 400 of FIG. 1E. Thecatheter 400 is illustrated in section in FIG. 1I along with relativepositions of the lumens 101 a, 102 a, 104 a, 105 a and 108 a, forexample. Also, FIG. 1I illustrates a relative position of theradioactive wire 107 within the lumen 102 a. The central lumen 102 aallows for selectively inserting and positioning the radioactive wire,such as the radioactive wire 107, or other suitable treatment medium,for the delivery of the medical treatment, for example.

The catheters 100, 300 and 400, and the various balloons and componentsthereof including the applicator extender balloon assembly 500 andcomponents thereof can be made of various suitable materials, including,for example, nylon, polyurethane, Polyether block amide Pebax®,poly(ethylene terephthalate), commonly abbreviated PET or otherthermoplastic elastomers. Nylon can be desirably used, since it can befused together with the catheter, for example.

Referring now to FIG. 2A, there is provided a multi-purpose balloonsingle intra-cavity catheter 200 having a plurality of various sizedballoons that may be arranged in a plurality of independent and distinctballoons groups, and can enable fixing, stabilizing or positioning ofradioactive material, such as radioactive wires, in a cavity, such as inthe esophagus or in other organs or in bodily or surgically createdcavities, to deliver a radiation dose or other therapeutic agent to atargeted portion of a body for the medical treatment. Moreover, thecatheter 200 can allow for diagnosing the anatomy of abnormal organshape by evaluating the balloon shape (with contrast agent) by comparingto shapes of normal healthy patient organs, for example.

FIG. 2A shows an embodiment of the catheter 200, similar to thestructure of the catheter 100 of FIG. 1A fitted with a secondarytreatment balloon 270 as shown in FIG. 2A that is adapted to receive aradioactive wire that encircles or is arranged in association with aninterior portion of the balloon for delivering a relatively higher doseof radiation and to position the balloon in the cavity or organ for themedical treatment. The balloon attached to the catheter 200 can includeouter and inner balloons to position and deliver the medical treatment.The outer balloon can also assist in protecting the inner balloon thatis adapted to receive the radioactive material, such as radioactivewire, or a therapeutic agent for the medical treatment, as to be furtherdescribed.

Referring now to the drawings in greater detail, there is illustrated inFIG. 2A an embodiment of the multi-purpose balloon single intra-cavitycatheter 200 according to the teachings of the invention. Themulti-purpose balloon single intra-cavity catheter 200 includes aproximal end portion 212, a central portion 214 having, for example, agenerally tubular shaped body 205, and a non-branching distal endportion 216, with the non-branching distal end portion 216 including asuitable marker such as an X-ray marker 221, to indicate a position ofthe non-branching distal end portion 216 of the catheter 200. The X-raymarker 221 typically can be gold, lead, tungsten or other heavy metalsuitable for X-ray visualization, or can be other suitable material,depending on the use or application, and should not be construed in alimiting sense.

The multi-purpose balloon single intra-cavity catheter 200 can be madeof various suitable materials, such as a polymeric material, such aspolyurethane or polyacrylic, among other examples, depending on the useor application, for example. Typically, a length 218 of themulti-purpose balloon single intra-cavity catheter 200 of FIG. 2A isabout 78 cm to the tip area from the base area of the multi-purposeballoon single intra-cavity catheter 200, but the catheter 200 can be ofvarious suitable lengths and dimensions, depending on the use orapplication, for example. A diameter 229 of the central portion 214 ofthe catheter 200 of FIG. 2A is typically 0.45 cm, but can be of varioussuitable diameters, depending on the use or application, for example.

The proximal end portion 212 of the catheter 200 includes the pluralityof neck portions 206 a, 206 b, 206 c, 206 d and 206 e, made of similarsuitable material as the catheter 200. The neck portions 206 a, 206 b,206 c, 206 d and 206 e each include a corresponding lumen 201 a, 202 a,203 a, 207 a and 209 a therein that extends from the proximal endportion 212, such as within the catheter 200, for balloon inflation orfor the delivery of the medical treatment, for example. The neckportions 206 a, 206 b, 206 c, 206 d and 206 e and corresponding lumens201 a, 202 a, 203 a, 207 a and 209 a are desirably associated with acorresponding suitable connector or connecting mechanism 201, 202, 203,207 and 209, such as suitable luer locks 201, 202, 203, 207 and 209,that can be a male or a female connection, for example.

For example, the luer-locks 203, 207 and 209 can be fitted with syringesfor selectively inflating balloons 215 a, 215 b, balloons 217 a, 217 b,and 217 c and balloon 219 to a predetermined size, for a particular useor application, for example. The balloons 215 a, 215 b, the balloons 217a, 217 b, and 217 c and the balloon 219 being desirably located inassociation with the central portion 214 to facilitate positioningand/or stabilizing the catheter 200 for delivery of a treatment. In thecatheter 200, the lumen 203 a associated with the luer lock 203 canreceive and remove a fluid medium, such as saline solution or a gaseousmedium, such as by a syringe or other suitable delivery mechanism, suchas a pump, to selectively inflate or deflate the balloons 217 a, 217 b,and 217 c, for example.

Also, the lumen 207 a associated with the luer lock 207 can receive andremove a fluid medium, such as saline solution or a gaseous medium, suchas by a syringe or other suitable delivery mechanism, such as a pump, toselectively inflate or deflate the balloon 219, for example. Similarly,the lumen 209 a associated with the luer lock 209 can receive and removea fluid medium, such as saline solution or a gaseous medium, such as bya syringe or other suitable delivery mechanism, such as a pump, toselectively inflate or deflate the balloons 215 a and 215 b, forexample. The locking mechanism or connector, such as provided by theluer locks 203, 207 and 209, when affixed to the catheter 200 canprovide for selectively not allowing or selectively allowing a fluidmedium, such as including fluids, fluid or gaseous mediums, or air, orallowing a contrast medium, for example, to pass through a correspondingconnecting point provided by the connector or connecting mechanism 203,207 and 209, such as luer locks, with the catheter 200. As illustratedin FIG. 2A, the balloons 215 a, 215 b, 217 a, 217 b, 217 c and 219 canbe arranged in a plurality of independent and distinct balloon groups inassociation with the central portion 214 of the catheter 200. Forexample, as illustrated from FIG. 2A, the balloons 215 a and 215 b canform a first independent and distinct balloon group, the balloons 217 a,217 b and 217 c can form a second independent and distinct balloongroup, and the balloon 219 can form a third independent and distinctballoon group. Each independent and distinct balloon group can beselectively inflated or deflated or can also receive or have removed acontrast liquid or other contrast medium independently of the balloonsof another independent and distinct balloon group, such as throughcorresponding ones of the plurality of connectors, such as connectors203, 207 and 209, and through the associated corresponding ones of theplurality of the lumens, such as lumens 203 a, 207 a and 209 a, forexample.

As depicted in FIG. 2A, the central lumen 202 a associated with theconnector 202, such as a luer lock, can be used to insert a radioactivewire 208 or a radioactive seed, for example, as a radiation source fortreatment at a specific or predetermined site or location of or withinthe organ or other cavity, into the catheter 200. Also, the centrallumen 202 a associated with the locking mechanism or connector 202, suchas a luer lock, can be used with suction or a syringe to remove bodilyfluids or material from a cavity in a body using the treatment catheter200, for example. The central lumen 202 a can be positioned in a largermain lumen 205 a extending through the catheter 200, as illustrated inFIG. 2A. The locking mechanism or connector 202 for the central lumen202 a can allow medical personnel to have a relatively easier controlleddelivery and guidance for the delivery of the medical treatment orextraction within a treatment area, for example.

Selectively inflating the balloons 215 a, 215 b, 217 a, 217 b, 217 c and219 can allow for selectively positioning and stabilizing the catheter200 for administration of the medical treatment or for removal of bodilyfluids or material in or within a cavity, such as in a bodily organ orin a cavity region, such as in or within the esophagus, rectum, stomachor a surgically created cavity, such as in or within the breast, anotherorgan or bodily tissue, such as through the lumen 202 a, for example.The lumens 203 a, 207 a and 209 a and the inflated balloons 215 a, 215b, 217 a, 217 b, 217 c and 219 can contain a contrast liquid or othercontrast medium, for contrast purposes in imaging applications. Thelumens 203 a, 207 a and 209 a can also be used for inflation ordeflation of the balloons 215 a, 215 b, 217 a, 217 b, 217 c and 219 forpositioning, stabilization and/or treatment, for example.

As discussed herein, the catheter 200 includes a plurality of balloons,such as the balloons 215 a, 215 b, 217 a, 217 b, 217 c and 219, arrangedin a plurality of independent and distinct balloon groups, such as thefirst balloon group including balloons 215 a and 215 b, the secondballoon group including balloons 217 a, 217 b, 217 c, and the thirdballoon group including balloon 219. The lumens of the catheter 200,such as the lumens 203 a, 207 a and 209 a, can be communicativelyconnected to a single or to any of various pluralities of balloons. Forexample, the lumen 203 a can be connected with balloons 217 a, 217 b,217 c of the second balloon group, the lumen 207 a can be connected tothe balloon 219 of the third balloon group, and the lumen 209 a can beconnected to balloons 215 a and 215 b of the first balloon group, asillustrated in FIG. 2A, for example. Also, the catheter 200 can have anyof various other suitable connection arrangements with more or lesslumens or balloons, depending on the use or application, for example.

Further, the balloons, such as the balloons 215 a, 215 b, 217 a, 217 b,217 c and 219, can have any of various suitable sizes or shapes, such ascylindrical, spherical, oval, oblong, toroidal, or other suitableshapes, depending on the use or application, for example. In thecatheter 200, the first independent and distinct balloon group includingballoons 215 a and 215 b, the second independent and distinct balloongroup including balloons 217 a, 217 b and 217 c, and the thirdindependent and distinct balloon group including balloon 219 each can beof a different size or shape from the balloons of the other groups, forexample, and can assist in positioning and stabilizing the catheter 200in a cavity, such as an organ, a body cavity or a surgically createdcavity, for the delivery of the medical treatment.

The lumens, such as the lumens 201 a, 202 a, 203 a, 207 a and 209 a, canhave any of various suitable sizes, shapes or configurations, such ascylindrical, rectangular, oval, or other suitable shapes orconfigurations, depending on the use or application, for example. Also,a typical dimension of a diameter of the lumens, such as indicated at211 for diameter of the lumen 203 a and as indicated at 225 for adiameter of the lumen 209 a, for inflating the corresponding balloons215 a, 215 b, 217 a, 217 b, 217 c and 219 can be typically in a range offrom about 0.8 mm to about 1.5 mm, for example, but can be of varioussuitable dimensions, depending on the use or application, and should notbe construed in a limiting sense.

Further, the spacing between each of the centers of adjacent ones of theballoons 217 a, 217 b and 217 c can, for example, correspond to thespacing between adjacent exit points of the lumen 203 a, can be a sameor a different spacing, depending on the use or application, such asdesirably being spaced apart by about 2.5 cm from each other asindicated at 223, for example. Also, the spacing between each ofadjacent balloons of the catheter 200, such as the balloons 215 a, 215b, 217 a, 217 b, 217 c and 219, can be same or different for each pairof adjacent balloons of the catheter 200, depending on the use orapplication, for example. The first balloon group including the balloons215 a and 215 b, the second balloon group including the balloons 217 a,217 b and 217 c, and the third balloon group including the balloon 219are each independently arranged from each other balloon group on thecatheter 200 along the length 218 of the catheter 200, as illustrated inFIG. 2A. Also, the lumens, such as the lumens 201 a, 202 a, 203 a, 207 aand 209 a, can be positioned within the interior of the catheter 200,such interior of the catheter 200 being indicated by the numeral 227, orcan be positioned or integrally formed on or in an exterior surface orlayer of the catheter 200, for example, depending on the use orapplication, for example.

The balloons, such as the balloons 215 a, 215 b, 217 a, 217 b, 217 c and219 can be made of nylon, polyurethane, Polyether block amide Pebax®,poly(ethylene terephthalate) commonly abbreviated PET, or otherthermoplastic elastomers or other suitable materials, depending on theuse or application, for example. Additionally, one or more of theballoons 215 a, 215 b, 217 a, 217 b, 217 c and 219 and all of, part ofor a portion of the catheter 200, such as including the body 205 of thecentral portion 214 of the catheter 200, can be coated or impregnatedwith various suitable coatings for ease of assembly such as a siliconetype coating, or the balloons, such as the balloons 215 a, 215 b, 217 a,217 b, 217 c and 219, and/or the catheter, such as the catheter 200, canbe impregnated or coated with various suitable therapeutic or medicinalagents for treatment at a site within the body, such as by elution ofthe agent from the balloon or the catheter, for example.

In an embodiment, all of, a part of or a portion of the catheter 200, aswell as one or more of the balloons associated with the catheter 200,such as the balloons 215 a, 215 b, 217 a, 217 b, 217 c and 219, can beuncoated or can be coated with a lubricant for lubrication for ease ofpositioning the catheter 200 at a treatment site, or can be coated orformed with antimicrobial or medicinal agents for the delivery of themedical treatment at the treatment site, for example. In this regard, invarious embodiments of catheters, such as the catheter 200, varioustherapeutic drugs or agents can be coated onto the surface of one ormore of the balloons, such as the balloons 215 a, 215 b, 217 a, 217 b,217 c and 219, or coated onto the surface of all of, part of or aportion of the catheter, such as the catheter 200, for releasing thetherapeutic drug or agent internally to a specific location of thecavity being treated.

The catheter 200 of FIG. 2A having a plurality of connectors or lockingmechanisms 201, 202, 203, 207 and 209, such as the luer-locks asexamples of connectors or locking mechanisms, and a plurality ofballoons, such as the balloons 215 a, 215 b, 217 a, 217 b, 217 c and219, can be inserted into various body cavities, such as the esophagus,but is not limited thereto and can also be inserted for the delivery ofthe medical treatment into other cavities, such as the rectum, vagina,etc., or surgically created cavities, wherein the radioactive wire, orother radioactive or therapeutic material or other therapeutic agent,can provide the requisite radiation dose or the medical treatment totreat cancerous growth or other medical conditions. Typically, thedimension of the radioactive wire, such as the radioactive wire 208,that can be inserted into the central lumen 202 a, is desirably in arange of about 0.5 mm to about 0.8 mm, for example, but can be ofvarious suitable dimensions and configurations depending on the use orapplication.

Desirably, the radioactive wire, such as the radioactive wire 208, ismade of a suitable radioactive material, such as Iridium-192, Cobalt 60and Yttrium 168, for example. The high dose rate (HDR) treatmentdelivered through the catheter, such as the catheter 200, can beconducted with Ir-192, Au-198, I-125 and Cs-131, for example. Typically,the dose of radiation delivered by the radioactive wire, such as theradioactive wire 208, is about 1 Curie to about 10 Curies per seed, butcan be any suitable dose, depending on the use or application.

Also, HDR afterloaders can be used in conjunction with embodiments ofthe catheters, such as the catheter 200, for delivery of a radiationdose for the medical treatment, such as Varisource, Gamma Med and BEBIGafterloaders or other suitable afterloaders, for example. For a low doserate (LDR) application delivered through embodiments of catheters, suchas the catheter 200, Sr-90 can be used in conjunction with the radiationwire, such as the radioactive wire 208, as well as Cs-131 and Yb-168 canbe used as the radiation source, for example. Typically, the dose ofradiation using the LDR configuration is usually one thousand times lessthan the HDR applications, such LDR dose being in a range of about 1milli Curie to about 10 milli Curies, for example.

An advantage, among others, of embodiments of catheters, such as thecatheter 200, is that it can allow for the delivery of the radiationdose or another therapeutic agent to a specific site or a predeterminedlocation of the organ or body cavity, such as via the radioactive wire208 through the central lumen 202 a. Further, embodiments of catheters,such as the catheter 200, can also allow for, at the same time or atdifferent times, the removal of fluid or bodily material from thetreatment site area, such as through the central lumen 202 a or througha main lumen 205 a that includes the central lumen 202 a, as well asprovide enhanced stabilization and/or positioning of the catheter fortreatment. The selective inflation or deflation of the correspondingballoons, such as the balloons 215 a, 215 b, 217 a, 217 b, 217 c and219, can allow for selectively controlling the size of each balloonindependently or in conjunction with one or more other balloons, toselectively adjust the location and positioning of the catheter at thetreatment site.

Also, the catheter 200 includes, such as illustrated in FIG. 2A, anembodiment of a secondary treatment balloon 270 at the non-branchingdistal end portion 216 of the catheter 200. The secondary treatmentballoon 270 can be selectively inflated or deflated to be positioned ina body cavity or a surgically created cavity for delivery of a radiationdose or other treatment agent to the surrounding tissue. In the catheter200, the lumen 201 a associated with a connector or locking mechanism201, such as a suitable luer lock, can receive and remove a fluidmedium, such as saline solution or a gaseous medium, such as by asyringe or other suitable delivery mechanism, such as a pump, toselectively inflate or deflate the secondary treatment balloon 270, forexample.

In the embodiment of the catheter 200, the secondary treatment balloon270 can be integrally formed with or affixed to or otherwise positionedin conjunction with the catheter 200, such as by a suitable glue oradhesive, for example, as indicated at attachment area 230. Thesecondary treatment balloon 270 has at least one or both of a firstsecondary treatment lumen 272 and a second secondary treatment lumen274. The first secondary treatment lumen 272 can be positioned inassociation with the periphery of the secondary treatment balloon 270,such as illustrated in FIG. 2A, for example, and can be integrallyformed with or affixed to or otherwise positioned in conjunction withthe secondary treatment balloon 270, such as by a suitable glue oradhesive, for example.

The first secondary treatment lumen 272 is desirably of a generallyspiral type configuration, for example, as illustrated in FIG. 2A. Thefirst secondary treatment lumen 272 can be positioned in associationwith the periphery of the secondary treatment balloon 270, such aseither on an interior surface or on an exterior surface of the secondarytreatment balloon 270, for example, but desirably is placed inassociation with an interior surface or portion thereof. The firstsecondary treatment lumen 272 is communicatively connected to thecentral lumen 202 a by a connector or connector portion 276 a or can beintegrally formed therewith to deliver a radioactive dose or othermedical treatment agent through the central lumen 202 a and through thefirst secondary treatment lumen 272 to a treatment site in a cavity,such as by insertion of the radioactive wire 208 or providing atherapeutic agent through the central lumen 202 a, the connector 276 aand the first secondary treatment lumen 272, for example.

The second secondary treatment lumen 274 is also communicativelyconnected to the central lumen 202 a by a connector or connector portion276 b, or can be integrally formed therewith to deliver a radioactivedose or other medical treatment agent through the central lumen 202 aand through the second secondary treatment lumen 274 to a treatment sitein a cavity, such as by insertion of the radioactive wire 208 orproviding a therapeutic agent through the central lumen 202 a, theconnector 276 b and the second secondary treatment lumen 274, forexample. The second secondary treatment lumen 274 is desirably formed inan interior portion of the secondary treatment balloon 270 desirablyextending in a generally longitudinal direction in a generally centralportion of the secondary treatment balloon 270, for example.

FIG. 2B shows the cross-sectional view taken along the 2B-2B plane ofthe catheter 200 of FIG. 2A. The catheter 200 is illustrated in sectionin FIG. 2B along with relative positions of the lumens 201 a, 202 a, 203a, 207 a and 209 a, for example. Also, FIG. 2B illustrates a relativeposition of the radioactive wire 208 within the central lumen 202 a. Thecentral lumen 202 a allows for selectively inserting and positioning theradioactive wire, such as the radioactive wire 208, or other suitabletreatment medium, for delivery of the medical treatment, for example.

Referring now to FIG. 2C, another embodiment of a catheter 600 isillustrated. The catheter 600 is similar to the catheter 200 of FIG. 2Aas to components and structure, as described, including the balloons 215a, 215 b, 217 a, 217 b, 217 c and 219, and the corresponding lumens 201a, 202 a, 203 a, 207 a and 209 a with the connectors or lockingmechanisms 201, 202, 203, 207 and 209, as described, and can be ofsuitable shapes, dimensions and materials, as described in relation tothe catheter 200. However, the catheter 600 also includes an additionalconnector or locking mechanism 213, such as a suitable luer lock, thatconnects to a neck portion 206 f of the catheter 600 associated with anadditional lumen 213 a, with the additional lumen 213 a and the lumen201 a associated with an embodiment of a secondary treatment balloonassembly 250 at the non-branching distal end portion 216 of the catheter600 that is illustrated in greater detail and further described hereinin relation to FIGS. 2D and 2E.

Referring to FIGS. 2C and 2D, in the embodiment of the catheter 600, thesecondary treatment balloon assembly 250 can be integrally formed withor affixed to or otherwise positioned in conjunction with the catheter600, such as by a suitable glue or adhesive, for example, as indicatedat attachment area 280. The secondary treatment balloon assembly 250includes a secondary treatment balloon 251 that includes an outersecondary treatment balloon 252 and an inner secondary treatment balloon254.

The outer secondary treatment balloon 252 and the inner secondarytreatment balloon 254 can be selectively inflated or deflated to bepositioned in a body cavity or a surgically created cavity to betreated, for example. The lumen 213 a is in communication with the innersecondary treatment balloon 254 and the lumen 201 a is in communicationwith the outer secondary treatment balloon 252 to respectivelyselectively inflate or deflate the inner secondary treatment balloon 254and the outer secondary treatment balloon 252 to position and/orstabilize the secondary treatment balloon 251, including the innersecondary treatment balloon 254 and/or the outer secondary treatmentballoon 252, in a body cavity or surgically created cavity to betreated. Similarly, the lumens 201 a and 213 a can receive or can removea fluid medium, as previously described, such as saline solution or agaseous medium, such as by a syringe or other suitable deliverymechanism, such as a pump, to selectively inflate or deflate the innersecondary treatment balloon 254 and the outer secondary treatmentballoon 252, to provide a corresponding balloon shape, size andconfiguration in the body cavity for the medical treatment, for example.

The secondary treatment balloon 251 has at least one or both of a firstsecondary treatment lumen 256 and a second secondary treatment lumen258, the second secondary treatment lumen 258 being optionally indicatedin FIG. 2D. The first secondary treatment lumen 256 can be positioned inassociation with the periphery of the inner secondary treatment balloon254 and can be integrally formed with or affixed to or otherwisepositioned in conjunction with the inner secondary treatment balloon254, such as by a suitable glue or adhesive, for example. The firstsecondary treatment lumen 256 is desirably of a generally spiral typeconfiguration, for example, as illustrated in FIGS. 2C and 2D. The firstsecondary treatment lumen 256 can be positioned in association with theperiphery of the inner secondary treatment balloon 254, such as eitheron an interior surface or on an exterior surface of the inner secondarytreatment balloon 254, for example, but desirably is placed on aninterior surface or portion thereof.

The first secondary treatment lumen 256 is communicatively connected tothe central lumen 202 a by a connector or connector portion 255 a, andthe central lumen 202 a can extend into a neck area 257 of the secondarytreatment balloon assembly 250 by a connector portion 208 a that can becommunicatively connected to or integrally formed with the central lumen202 a, to deliver a radioactive dose or other medical treatment agentthrough the central lumen 202 a, through the connector or connectorportion 255 a and through the first secondary treatment lumen 256 to atreatment site or a predetermined location in a cavity, such as byinsertion of the radioactive wire 208 or providing a therapeutic agentthrough the central lumen 202 a through the neck area 257, the connector255 a and the first secondary treatment lumen 256, for example.

In the inner secondary treatment balloon 254, the second secondarytreatment lumen 258 can be integrally formed with or affixed to orotherwise positioned in conjunction with the inner secondary treatmentballoon 254, such as by a suitable glue or adhesive, for example. Thesecond secondary treatment lumen 258 is desirably formed in an interiorportion of the inner secondary treatment balloon 254 desirably extendingin a generally longitudinal direction in a generally central portion ofthe inner secondary treatment balloon 254, for example.

The second secondary treatment lumen 258 is also communicativelyconnected to the central lumen 202 a by a connector or connector portion255 b, or can be integrally formed therewith to deliver a radioactivedose or other medical treatment agent through the central lumen 202 a,the connector 255 b and through the second secondary treatment lumen 258to a treatment site in a cavity, such as by insertion of the radioactivewire 208 or providing a therapeutic agent through the central lumen 202a, the connector 255 b and the second secondary treatment lumen 258, forexample. The central lumen 202 a can extend into the neck area 257 ofthe secondary treatment balloon assembly 250 by the connector portion208 a that can be communicatively connected to or integrally formed withthe central lumen 202 a, to deliver a radioactive dose or other medicaltreatment through the central lumen 202 a to a treatment site in acavity, such as by insertion of the radioactive wire 208 or providing atherapeutic agent through the central lumen 202 a through the neck area257, the connector 255 b and the second secondary treatment lumen 258,for example.

Referring now to FIG. 2E, there is illustrated the catheter 600 with anembodiment of the secondary treatment balloon assembly 250 that includessimilar components and structure to that described with respect to thesecondary treatment balloon assembly 250 illustrated in FIGS. 2C and 2D.However, in the secondary treatment balloon assembly 250 of FIG. 2E,there can be included a connector or locking mechanism 240, such as asuitable luer lock, that can include suitable male or female connectorsto selectively connect the secondary treatment balloon assembly 250 tothe catheter 600.

The connector or locking mechanism 240 or a portion thereof can beintegrally formed with or suitably connected with the distal end portion216 of the catheter 600 at an area 241, such as with a suitable glue oradhesive, for example. Also, the connector or locking mechanism 240 or aportion thereof can be integrally formed with or suitably connected withthe proximal end of the neck area 257 of the secondary treatment balloonassembly 250 at the area 241, such as with a suitable glue or adhesive.Such connector or locking mechanism 240 can assist in enabling attachingor exchanging with the catheter 600 various sizes and configurations ofthe secondary treatment balloon assembly 250 at the area 241 tofacilitate treatment and treatment options, for example. Further, inFIG. 2E, the inner secondary treatment balloon 254 only includes thefirst secondary treatment lumen 256 and the connector 255 a, with thesecond secondary treatment lumen 258 and the connector 255 b beingoptionally indicated by dashed lines therein.

Also, in the secondary treatment balloon assembly 250 illustrated anddescribed with respect to FIGS. 2C, 2D and 2E, the lumens 201 a, 202 aand 213 a can also be extended through the neck area 257 by one or moresuitable connector lumens, that can be integrally formed or joinedtherewith by a suitable process or method, to respectively communicatewith such corresponding connector lumens in the neck area 257 that cancorrespondingly communicatively connect or communicatively associate thelumens 201 a, 202 a and 213 a with the connectors 255 a, 255 b, theinner secondary treatment balloon 254, the outer secondary treatmentballoon 252, the first secondary treatment lumen 256 and the secondsecondary treatment lumen 258, as described.

Referring now to FIG. 2F, there is illustrated a cross-sectional planarview taken along the 2F-2F plane of the catheter 600 of FIG. 2C. Thecatheter 600 is illustrated in section in FIG. 2F along with relativepositions of the lumens 201 a, 202 a, 203 a, 207 a, 209 a and 213 a, forexample. Also, FIG. 2F illustrates a relative position of theradioactive wire 208 within the lumen 202 a. The central lumen 202 aallows for selectively inserting and positioning the radioactive wire,such as the radioactive wire 208, or for selectively providing othersuitable treatment mediums, for delivery of the medical treatment, forexample.

While various embodiments of inflatable balloons of embodiments of themulti-purpose balloon catheters described herein have been associatedwith a single spiral or a circular treatment lumen or a single treatmentlumen, or associated with first and second treatment lumens, positionedin association with a distal inflatable balloon of the catheter,embodiments of distal inflatable balloons for delivery of treatmentshould not be construed to be so limiting. In this regard, a distalinflatable balloon for treatment can include a relatively large numberof treatment lumens associated with a corresponding distal inflatableballoon. For example, a distal inflatable balloon for the delivery of amedical treatment can include one to fifteen treatment lumens associatedwith or attached to a distal inflatable balloon, desirably attached toor associated with an inner wall or inner surface of the balloon orattached to or associated with an inner balloon of a distal inflatableballoon.

Such multiple treatment lumens associated with a distal inflatableballoon can be selectively used for the delivery of a plurality oftreatments, procedures, or other therapeutic purposes, such as for thedelivery of radiation therapy, delivery of contrast agents for imagingor mapping a location, delivery of various therapeutic agents, etc., forexample, using a single distal balloon associated with a catheter,similar to those described herein. For example, a distal inflatableballoon associated with a catheter for treatment or a related proceduredesirably can include five such treatment lumens, such as one treatmentlumen being positioned at a center of an inner treatment balloon andfour treatment lumens positioned in association with the periphery ofthe inner treatment balloon.

It is to be understood that the present invention is not limited to theembodiments described above, but encompasses any and all embodimentswithin the scope of the following claims.

I claim:
 1. A multi-purpose balloon intra-cavity catheter for a medicaltreatment, comprising: a single intra-cavity catheter configured forinsertion into a body cavity for the medical treatment, the singleintra-cavity catheter having a proximal end portion, a central portionand a non-branching distal end portion; a plurality of lumens positionedin association with the single intra-cavity catheter extending from theproximal end portion of the single intra-cavity catheter; a plurality ofindependent and distinct balloon groups positioned in association withthe central portion of the single intra-cavity catheter, eachindependent and distinct balloon group being independently spaced fromeach other independent and distinct balloon group on the singleintra-cavity catheter, each independent and distinct balloon grouppositioned in a non-overlapping contiguous arrangement on a samelongitudinal axis of the single intra-cavity catheter, each of theplurality of independent and distinct balloon groups including at leastone inflatable balloon, and each of the plurality of independent anddistinct balloon groups being communicatively associated with acorresponding at least one of the plurality of lumens, wherein theplurality of lumens includes a central lumen coaxially positioned withina larger main lumen extending longitudinally through the singleintra-cavity catheter to the distal end portion; and a secondarytreatment balloon communicatively associated with the non-branchingdistal end portion of the single intra-cavity catheter, the secondarytreatment balloon being in communication with the central lumen, thecentral lumen in communication with the secondary treatment balloonbeing configured to one or more of respectively receive and toselectively provide at least one of a liquid saline solution, a fluidmedium, a gaseous medium, a contrast medium, a radioactive material orother treatment medium for the medical treatment or enable selectivelyinflating or deflating the secondary treatment balloon to one or more ofselectively position or stabilize the secondary treatment balloon forthe medical treatment.
 2. The multi-purpose balloon intra-cavitycatheter according to claim 1, wherein the secondary treatment balloonfurther comprises: at least one secondary treatment lumen positioned inassociation with the secondary treatment balloon, each of the at leastone secondary treatment lumen being respectively communicativelyconnected with the central lumen in communication with the secondarytreatment balloon, wherein the at least one secondary treatment lumen isconfigured to respectively receive and to selectively provide to thesecondary treatment balloon at least one of the liquid saline solution,the fluid medium, the gaseous medium, the contrast medium, theradioactive material or the other treatment medium for the medicaltreatment.
 3. The multi-purpose balloon intra-cavity catheter accordingto claim 1, wherein the secondary treatment balloon further comprises: aplurality of secondary treatment lumens positioned in association withan interior portion of the secondary treatment balloon, each of theplurality of secondary treatment lumens being respectivelycommunicatively connected with the central lumen in communication withthe secondary treatment balloon, wherein each of the plurality ofsecondary treatment lumens are configured to respectively receive and toselectively provide to the secondary treatment balloon at least one ofthe liquid saline solution, the fluid medium, the gaseous medium, thecontrast medium, the radioactive material or the other treatment mediumfor the medical treatment.
 4. The multi-purpose balloon intra-cavitycatheter according to claim 1, wherein the secondary treatment balloonfurther comprises: at least one first secondary treatment lumenpositioned in association with a periphery of the secondary treatmentballoon, each of the at least one first secondary treatment lumen beingrespectively communicatively connected with the central lumen incommunication with the secondary treatment balloon, wherein the at leastone first secondary treatment lumen is configured to respectivelyreceive and to selectively provide to the secondary treatment balloon atleast one of the liquid saline solution, the fluid medium, the gaseousmedium, the contrast medium, the radioactive material or the othertreatment medium for the medical treatment; and at least one secondsecondary treatment lumen positioned in an interior central portion ofthe secondary treatment balloon, each of the at least one secondsecondary treatment lumen being respectively communicatively connectedwith the central lumen in communication with the secondary treatmentballoon, wherein the at least one second secondary treatment lumen isconfigured to respectively receive and to selectively provide to thesecondary treatment balloon at least one of the liquid saline solution,the fluid medium, the gaseous medium, the contrast medium, theradioactive material or the other treatment medium for the medicaltreatment.
 5. The multi-purpose balloon intra-cavity catheter accordingto claim 4, wherein: the at least one first secondary treatment lumenhas a generally spiral configuration; and the at least one secondsecondary treatment lumen extends in a generally longitudinal directionin a generally central portion of the secondary treatment balloon. 6.The multi-purpose balloon intra-cavity catheter according to claim 1,further comprising: a plurality of connectors positioned in associationwith the proximal end portion of the catheter, each of the plurality ofconnectors being respectively communicatively connected to acorresponding at least one of the plurality of lumens, each of theplurality of connectors being configured to enable respectivelyselectively receiving or removing through a corresponding lumen one ormore of the liquid saline solution, the fluid medium, the gaseousmedium, the contrast medium, the radioactive material or the othertreatment medium for the medical treatment.
 7. The multi-purpose balloonintra-cavity catheter according to claim 1, wherein: the body cavity forthe medical treatment is selected from the group consisting of anesophagus, a rectum, a vagina and a surgically created cavity.
 8. Themulti-purpose balloon intra-cavity catheter according to claim 1,wherein: the single intra-cavity catheter comprises polyurethane.
 9. Themulti-purpose balloon intra-cavity catheter according to claim 1,wherein: the at least one inflatable balloon in each of the plurality ofballoon groups has a shape selected from the group consisting of acylindrical shape, a rectangular shape, an oval shape and a sphericalshape.
 10. The multi-purpose balloon intra-cavity catheter according toclaim 1, wherein: the at least one inflatable balloon in each of theplurality of balloon groups is made of a material selected from thegroup consisting of nylon, polyurethane, polyether block amide, andpolyethylene terephthalate or a combination thereof.
 11. Themulti-purpose balloon intra-cavity catheter according to claim 1,wherein: at least one portion of the single intra-cavity catheter or theat least one inflatable balloon in at least one of the plurality ofindependent and distinct balloon groups is coated with a medicinal agentfor releasing the medicinal agent internally to a predetermined locationin the body cavity in association with or for the medical treatment. 12.The multi-purpose balloon intra-cavity catheter according to claim 1,wherein: at least one of the plurality of lumens is configured toreceive the radioactive material for the medical treatment.
 13. Themulti-purpose balloon intra-cavity catheter according to claim 12,wherein: the radioactive material includes at least one of a radioactivewire or a radioactive seed.
 14. The multi-purpose balloon intra-cavitycatheter according to claim 12, wherein: the radioactive material isselected from the group consisting of Ir-192, Au-198, I-125 and Cs-131.15. The multi-purpose balloon intra-cavity catheter according to claim14, wherein: the radioactive material delivers a dose of radiationranging from 1 Curie to 10 Curies.
 16. A multi-purpose balloonintra-cavity catheter for a medical treatment, comprising: a singleintra-cavity catheter configured for insertion into a body cavity forthe medical treatment, the single intra-cavity catheter having aproximal end portion, a central portion and a non-branching distal endportion; a plurality of lumens positioned in association with the singleintra-cavity catheter extending from the proximal end portion of thesingle intra-cavity catheter; a plurality of independent and distinctballoon groups positioned in association with the central portion of thesingle intra-cavity catheter, each independent and distinct balloongroup being independently spaced from each other independent anddistinct balloon group on the single intra-cavity catheter, eachindependent and distinct balloon group positioned in a non-overlappingcontiguous arrangement on a same longitudinal axis of the singleintra-cavity catheter, each of the plurality of independent and distinctballoon groups including at least one inflatable balloon, and each ofthe plurality of independent and distinct balloon groups beingcommunicatively associated with a corresponding at least one of theplurality of lumens, wherein the plurality of lumens includes a centrallumen coaxially positioned within a larger main lumen extendinglongitudinally through the single intra-cavity catheter to the distalend portion; and a secondary treatment balloon communicativelyassociated with the non-branching distal end portion of the singleintra-cavity catheter, the secondary treatment balloon being incommunication with the central lumen, the central lumen in communicationwith the secondary treatment balloon being configured to one or more ofrespectively receive and to selectively provide at least one of a liquidsaline solution, a fluid medium, a gaseous medium, a contrast medium, aradioactive material or other treatment medium for the medical treatmentor enable selectively inflating or deflating the secondary treatmentballoon to one or more of selectively position or stabilize thesecondary treatment balloon for the medical treatment, wherein thesecondary treatment balloon further comprises at least one firstsecondary treatment lumen positioned in association with a periphery ofthe secondary treatment balloon and at least one second secondarytreatment lumen positioned in an interior central portion of thesecondary treatment balloon, the at least one first secondary treatmentlumen and the at least one second secondary treatment lumen beingrespectively communicatively connected with the central lumen incommunication with the secondary treatment balloon, wherein the at leastone first secondary treatment lumen and the at least one secondsecondary treatment lumen are configured to respectively receive and toselectively provide to the secondary treatment balloon at least one ofthe liquid saline solution, the fluid medium, the gaseous medium, thecontrast medium, the radioactive material or the other treatment mediumfor the medical treatment.
 17. The multi-purpose balloon intra-cavitycatheter according to claim 16, wherein: the at least one firstsecondary treatment lumen has a generally spiral configuration; and theat least one second secondary treatment lumen extends in a generallylongitudinal direction in a generally central portion of the secondarytreatment balloon.
 18. The multi-purpose balloon intra-cavity catheteraccording to claim 16, wherein: at least one of the plurality of lumensis configured to receive the radioactive material for the medicaltreatment.
 19. The multi-purpose balloon intra-cavity catheter accordingto claim 18, wherein: the radioactive material includes at least one ofa radioactive wire or a radioactive seed.
 20. The multi-purpose balloonintra-cavity catheter according to claim 18, wherein: the radioactivematerial is selected from the group consisting of Ir-192, Au-198, I-125and Cs-131.